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Completed

NCT Number: NCT05433688

Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS). Patient will be randomly allocated in a 1:1 ratio to either the UBS group or the CS group to perform the gastro-jejunal anastomosis (GJA) and the jejuno-jejunal anastomosis (JJA).

The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing an elective, primary robotic, assisted gastric bypass surgery (with a BMI ≥40 kg/m2 or with a BMI ≥35 kg/m2) with one or more of the following comorbidities: refractory arterial hypertension, type 2 diabetes mellitus and/or proven sleep apnea) with the need to close the gastro-jejunal anastomosis (GJA) and jejuno-jejunal anastomosis (JJA).
  • Age ≥18 years
  • Written informed consent

Exclusion criteria

  • Emergency surgery
  • Previous gastric surgery
  • History of chronic steroid use
  • Pregnancy or breastfeeding
  • Patients with hypersensitivity or allergy to the suture material
  • Non compliance
  • Participation in another randomized controlled trial

Treatment and study plan

Robotic assisted gastric bypass surgery

Device

The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Primary outcomes

  1. Time to perform the anastomosis

    Time frame: intraoperatively

    Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis

Secondary outcomes

  1. Anastomotic leak rate over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of patients having Anastomotic leak at each examination

  2. Anastomosis stenosis rate over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of patients having Anastomosis stenosis at each examination

  3. Gastric fistula rate over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of patients having Gastric fistula at each examination

  4. Rate of Obstruction over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of patients having obstruction of the anastomosis at each examination

  5. Rate of Anastomosis bleeding over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of patients having anastomosis bleeding at each examination

  6. Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of other complications classified according to "Clavien-Dindo" classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life

  7. Rate of Re-anastomosis over postoperative period

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    Number of re-anastomosis at each examination

  8. Total operation duration

    Time frame: intraoperatively

    time from cut to closure in minutes. The time is rounded up and only whole numbers are used

  9. Total procedure costs

    Time frame: until discharge approximately 10 days after surgery

    Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day)

  10. Length of postoperative stay

    Time frame: until discharge approximately 10 days after surgery

    Number of days after surgery until the patient is discharged from hospital

  11. Patient satisfaction (VAS)

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    With the Visual Analogue Scale from 0 mm - 100 mm the satisfaction of the patient will be evaluated with 0 (not satisfied at all) to 100 (very satisfied).

  12. Patient pain (VAS)

    Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

    With the Visual Analogue Scale from 0 mm - 100 mm the pain of the patient will be evaluated with 0 (no pain) to 100 (worst pain).

  13. Bariatric Analysis and Reporting Outcome System (BAROS)

    Time frame: preoperative, 30 days and 12 months post-surgery

    questionnaire a common tool to evaluate patient's outcome and quality of life before and after bariatric surgeries. Three main parameters are evaluated with this tool, the weight, the medical conditions and the quality of life. The weight and the medical conditions will be evaluated by the physician. The questions regarding the quality of life will be answered directly by the patients. The six categories (felling, sexual activities, physical activities, work, food and social contacts) can be answered on scale with 10 steps from very good to very bad.

  14. Course of Health Status measured with EQ-5D-5L Score

    Time frame: preoperative, 30 days and 12 months post-surgery

    EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

  15. Assessment of the handling of the unidirectional barbed suture

    Time frame: intraoperatively

    intra-operatively including different dimensions with 5 evaluations levels (excellent, very good, good, satisfied, poor).

  16. Assessment of the barbed suture compared to a conventional suture

    Time frame: intraoperatively

    Handling of barbed suture compared to a conventional suture (degree of difficulties and ease of handling) measured in two categories with a 5 point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Prospective, Mono-center, Randomized, Single-blinded, Controlled Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

Acronym: BARGASTRO

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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